MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SMART CONTROL VASCULAR STNT SYSTEM 7MM X 40, 6F; STENT, ILIAC

Model Number N/A

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

A smart control he 7 x 40 iliac self-expanding stent (ses) was delivered along the 35-inch non-cordis wire.However, it got stuck in the middle.It felt like it was delivered to the controller, but it could not proceed from there.The non-cordis wire did not come out from the guide wire port, so it was removed from the patient¿s body.Therefore, it was replaced with a new smart control stent and it could be implanted.Analysis of the returned device indicated the outer sheath was torn at approximately 6cm from the strain relief and the braid wires were observed exposed on the torn area.The smart control stent was attempted to be implanted at the superior mesenteric artery (sma).A 35-inch non-cordis wire was inserted.There was no reported patient injury.The product was returned for analysis.A non-sterile smart control, iliac 7x40ml was received coiled inside a plastic bag.Pin lock was received in-place.Per visual analysis, stent was not deployed.The outer sheath was observed torn approximately at 6 cm from the strain relief, braid wires were observed exposed on the torn area.No other anomalies were observed on the unit.Per functional analysis, the device couldn¿t be flushed due to the torn condition observed on the outer sheath.Nevertheless, a.035¿ guide wire lab sample was introduced from the hub to the torn area and from the distal tip to the torn area, and insertion/withdrawal was successfully performed, neither resistance nor obstruction was experienced during the procedure.Per microscopic analysis, results showed the torn area of the outer sheath of the smart control, iliac 7x40 unit presented evidence of elongations.Plastic deformation resulting in thickness reduction were observed on braid wires.Also, ductile dimples were found on the separated braid wire surfaces.The elongations found on the outer sheath material, the ductile dimples and plastic deformations resulting in thickness reduction, are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the outer sheath material was induced to a tensile force that exceeded the braid wire and outer sheath material yield strength prior to the separation.No other anomalies were observed during the microscopic analysis.A product history record (phr) review of lot 17882489 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen (inner shaft) - resistance/friction - in patient¿ was not confirmed since insertion/withdrawal test was successfully performed; neither resistance nor obstruction was experienced during the procedure.However, during analysis, it was noted that the outer sheath was observed torn and braid wires were observed exposed.Per microscopic analysis on the torn outer sheath, results showed that the observed torn area on the outer sheath presented evidence of elongations and its braid wires presented plastic deformation, thickness reduction and ductile dimples.The previous material characteristics/damages observed on the outer sheath are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the outer sheath material was induced to a tensile force that exceeded the braid wire and outer sheath material yield strength prior to the material separation.Per the observed damage condition of the unit as received, it is probable that procedural and or handling factors such as the user¿s interaction with the device and or vessel characteristics (although unknown) may have contributed to the torn outer sheath.However, the cause of the torn outer sheath could not be conclusively determined during the analysis.According to the instructions for use, which are not intended as a mitigation of risk, ¿advance the stent delivery system over the guidewire through the sheath introducer to the lesion site.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Caution: always use an appropriate size introducer sheath for the implant procedure to protect vessel and access site.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, the 7 x 40 smart control iliac self-expanding stent (ses) was delivered along the 35-inch non-cordis wire.However, it got stuck in the middle.It felt like it was delivered to the controller, but it could not proceed from there.The non-cordis wire did not come out from the guide wire port, so it was removed from the patient¿s body.Therefore, it was replaced with a new smart control stent and it could be implanted.There was no reported patient injury.Analysis of the returned device indicated the outer sheath was torn at approximately 6cm from the strain relief and the braid wires were observed exposed on the torn area.The smart control stent was attempted to be implanted at the superior mesenteric artery (sma).A 35-inch non-cordis wire was inserted.The device will be returned for analysis.

• Brand Name: SMART CONTROL VASCULAR STNT SYSTEM 7MM X 40, 6F
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer (Section G): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 11680615
• MDR Text Key: 247767269
• Report Number: 9616099-2021-04421
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032023792
• UDI-Public: 20705032023792
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: C07040ML
• Device Lot Number: 17882489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1